Ignite Creation Date:
2024-05-05 @ 12:04 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00234026
Status:
COMPLETED
Last Update Posted:
2012-06-05
First Post:
2005-10-05
Brief Title:
Gemcitabine in Treating Patients With Newly Diagnosed Relapsed or Chemotherapy-Resistant Mantle Cell Lymphoma
Sponsor:
Swiss Group for Clinical Cancer Research
Organization:
Swiss Group for Clinical Cancer Research
Study Overview
Official Title:
Master Protocol for Mantle Cell Lymphoma A Multicenter Phase II Trial Testing Gemcitabine for the Treatment of Patients With Newly Diagnosed Relapsed or Chemotherapy Resistant Mantle Cell Lymphoma
Status:
COMPLETED
Status Verified Date:
2012-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy such as gemcitabine work in different ways to stop the growth of cancer cells either by killing the cells or by stopping them from dividing
PURPOSE This phase II trial is studying how well gemcitabine works in treating patients with newly diagnosed relapsed or chemotherapy-resistant mantle cell lymphoma
PURPOSE This phase II trial is studying how well gemcitabine works in treating patients with newly diagnosed relapsed or chemotherapy-resistant mantle cell lymphoma
Detailed Description:
OBJECTIVES
Primary
Determine the efficacy of gemcitabine in terms of objective response and tolerability in patients with newly diagnosed relapsed or chemotherapy-resistant mantle cell lymphoma
Secondary
Determine the time to progression and time to treatment failure in patients treated with this drug
Determine the response duration in patients treated with this drug
Determine the adverse reactions in patients treated with this drug
OUTLINE This is a multicenter study
Patients receive gemcitabine IV over 30 minutes on days 1 and 8 Treatment repeats every 3 weeks for up to 9 courses in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed every 3 months for 1 year every 6 months for 1 year and then annually for 3 years
PROJECTED ACCRUAL A total of 10-29 patients will be accrued for this study within 2 years
Primary
Determine the efficacy of gemcitabine in terms of objective response and tolerability in patients with newly diagnosed relapsed or chemotherapy-resistant mantle cell lymphoma
Secondary
Determine the time to progression and time to treatment failure in patients treated with this drug
Determine the response duration in patients treated with this drug
Determine the adverse reactions in patients treated with this drug
OUTLINE This is a multicenter study
Patients receive gemcitabine IV over 30 minutes on days 1 and 8 Treatment repeats every 3 weeks for up to 9 courses in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed every 3 months for 1 year every 6 months for 1 year and then annually for 3 years
PROJECTED ACCRUAL A total of 10-29 patients will be accrued for this study within 2 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EU-20523 | None | None | None |